Efficacy and Safety of Ozonised Oil (HOO) in COVID-19 Patients

SARS-CoV Infection Clinical Trial

— HOO-COVID  

Official title:

Efficacy and Safety of Ozonised Oil (HOO) as Adjuvant Nutrition Supplement in COVID-19 Patients With Mild-to-Moderate Disease - HOO-COVID Project

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04651387
• Other study ID #: DEP_052020
• Status: Withdrawn
• Phase: N/A
• Start date: July 2021
• Est. completion date: December 2021

Study information

• Verified date: January 2022
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.

Description:

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. Indeed, in this form, ozone is extremely volatile and its beneficial effects are only transient. Furthermore, in these studies ozone was administered by auto-hemo-transfusion, an invasive approach that cannot be pursued for preventive purposes in healthy subjects or in severely affected patients. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. A challenge test was developed to identify new strategies to prevent Covid-19 infection. Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR. The ability to inhibit viral infection by UV radiation, hydrogen peroxide, anti-spike Covid-19 antibodies and HOO was comparatively evaluated. The only agent able to fully neutralize Covid-19 was HOO. The HOO efficacy in preventing finding is due to (a) the high sensitivity of Covid-19 to oxidative stress; (b) the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO; (c) the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites; (d) the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly; (e) HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation, thromboxane release and consequent pulmonary thrombo-embolism, a severe complication occurring in Covid-19 patients; (f) the increased oxygen availability in lung parenchyma. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill. This study is conducted as an open-label, prospective, controlled, multi-center randomized clinical trial on 74 COVID-19 patients (both sex , aged 18-80 years). In addition to the routine standard treatments for COVID-19, in the intervention group, combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" will be administered 3 times per day and will be prescribed for 2 weeks (14 days). For the control group, the placebo will be not considered and they will follow the routine standard treatments for COVID-19. The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 (main outcome). Additionally, secondary objectives will be the assessment of the temporal profile of viral load, the proportion of patients with virological clearance, the hospitalization duration stay, intensive care admission and time to, the COVID-19 Severity and in-hospital mortality.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Real time PCR-approved positive COVID-19 test (nasopharyngeal swabs).
• Both gender
• Age between 18 and 80 years
• Lack of participation in other clinical trials
• COVID-19 Severity Score = 5
• Hospitalized =48 hours.
• Signing informed consent and willingness of the participant to accept randomization to any assigned treatment

Exclusion Criteria:

• Pregnancy and breastfeeding.
• BMI =35 kg/m2
• Severe and critical COVID-19 pneumonia (COVID-19 Severity Score > 5)
• Patient connected to the ventilator
• SaO2 less than 80%
• Having liver failure, chronic hepatitis, cirrhosis, and cholestatic liver diseases
• Any severe medical condition with a prognosis of < 6 months
• Alcohol and drug abuse (during the last 30 days)
• History of known allergy to peanuts

Related Conditions & MeSH terms

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Dietary Supplement:
• Ozonized oil (HOO
In addition to the routine standard treatments for COVID-19, in the intervention group, combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" will be administered 3 times per day (after breakfast, lunch, dinner, possibly with a delay of one hour from the routine treatment) and will be prescribed for 2 weeks (14 days). Posology: 3 HOO capsules plus 3 HOO intranasal administrations for each naris plus 3 HOO oropharyngeal administrations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load of SARS-CoV-2	The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 at day 7.	up to one week
Secondary	The temporal profile of viral load of SARS-CoV-2	The temporal profile of viral load at baseline, day 7, 14 and 28	up to four weeks
Secondary	The proportion of patients with virological clearance	The proportion of patients with virological clearance at day 14 and 28	up to four weeks
Secondary	SaO2	Increasing SaO2, day 7, 14 and 28	up to four weeks
Secondary	hospitalization stay	The hospitalization duration stay	through study completion, an average of 3 months
Secondary	Intensive care	Intensive care admission and time to	through study completion, an average of 3 months
Secondary	COVID-19 Severity Score	The COVID-19 Severity Score at day 14 and 28 Score definition: 1 is "no limitation of activities"; 2 is "limitation of activities"; 3 is "hospitalized, no oxygen therapy"; 4 is " hospitalized, oxygen by mask or nasal prongs"; 5 is "non-invasive ventilation or high-flow oxygen"; 6 is "intubation and mechanical ventilation"; 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".	up to four weeks
Secondary	in-hospital mortality	Death occurred during hospitalization.	through study completion, an average of 3 months